3rd Annual Jefferson Urology Symposium: Men’s Health Forum

© The Canadian Journal of Urology TM : International Supplement, August 2020 with improvements inMSHQ-EjD bother parameters, IIEF-5, and MSHQ-EjD function scores up to 2 years. 39 To date, the largest, multinational, prospective randomized controlled trial investigating PUL is the L.I.F.T. study comparing PUL to a sham control with reported outcomes of up to 5 years. 40,41 At 5 years, improvements were durable in IPSS (36%), QoL (50%), BPHII (52%), and Qmax (44%), with no difference seen between Intent to Treat and Per Protocol populations. Furthermore, sexual function was stable over 5 years with no de novo, sustained erectile, or ejaculatory dysfunction. In another randomized prospective controlled trial known as the BPH6 study, PUL was compared to the gold standard TURP with 2 year published outcomes data. 42 This study demonstrated that while significant improvements in IPSS, IPSS QoL, BPHII, and QMax were observed in both groups through 2 years, PULwas superior to TURP in quality of recovery, ejaculatory function preservation, and performance on the composite BPH6 index. However, TURP demonstrated superior change in IPSS and Qmax. There were no statistically significant differences between the study arms in IPSS QoL, and BPHII score and no significant change in ejaculatory function bother scores in either arm. Interestingly, PUL resulted in a statistically significant improvement in sleep. Intending to simulate PUL in a day-to-day clinical setting without the rigid exclusion criteria of clinical studies, Sievert et al investigated PUL outcomes in patients with confirmed moderate-to-severe BPH- related LUTS, who were unresponsive to oral therapy, andwere surgical candidates for TURP. 43 Patients were included regardless of prostate size, PVR, or history of retention, with the only exclusion criteria being presence of an obstructive median lobe. Out of 212 men, 86 chose PUL with a mean of 3.8 (2-7) implants placed in patients 38-85 years old with prostate sizes ranging 17-111 mL. Even with these looser exclusion criteria, within 1 month of surgery, 86% (74/86) of patients reported substantial symptom relief with significant improvements in Qmax, PVR, IPSS, and QoL (p < 0.001) that was maintained at 2 year follow up. Notably, sexual function was unchanged or improved and no Clavien-Dindo Grade ≥ 2 adverse events were reported postoperatively. However, 12.8% (11/86) of patients were retreated over the 2 year followup period, compared to 2 year retreatment rates reported in the L.I.F.T. study (7.5%). 44 Nonetheless, the study demonstrated that PUL is an effective and promising surgical technique, with potential benefits in menwith larger prostates than currently recommended in guidelines. To better explore PUL efficacy, Eure et al retrospectively analyzed 1413 consecutive patients who received PUL with reported comparisons to the L.I.F.T. study in baseline demographics and symptom outcomes. 45 Patients in the real-world retrospective (RWR) study were modestly older (p < 0.001) and less symptomatic (IPSS [p < 0.0001], QoL [p < 0.0001], Qmax [p < 0.0001], PVR [< 0.001]) compared to those in the L.I.F.T. study. Thirty-eight patients with prostates ≥ 80 cc experienced similar absolute symptom scores throughout 6 months of follow up compared to those with smaller prostates less than 80 cc (IPSS baseline: 19.4 versus 17.6, p=0.1; 1month: 10.6 versus 9.0, p=0.3; 6months: 10.0 versus 9.6, p=0.8). These results suggest that patients with prostates larger than 80 grams may still benefit fromPUL. In fact, the FDArecently granted NeoTract/Teleflex Inc. an expanded indication for the use of Urolift to treat prostates up to 100 grams. However, further investigation should be performed before widespread use in larger prostates, with current AUAguidelines for surgical management of BPH still recommends an upper limit of 80 grams. 5 In addition to prostate size, patient anatomy must be considered for men who desire PUL. Current guidelines recommend against using Urolift in men with large median lobes. This guideline has recently been challenged in the literature. Urolift is currently indicated for treating lateral lobe hyperplasia, with implants deployed at the 2 and 10 o’clock positions when viewing the transverse plane of the urethra. However, for treating median lobes, the implants are intended to affix the obstructing portion laterally to the prostatic urethra and should be deployed anterior to the 4 or 8 o’clock positions to avoid damage to the neurovascular bundles. This method opens the bladder neck and reduces the “ball-valve” effect caused by enlarged median lobes. MedLift examined the safety and efficacy of PUL in treating obstructing median lobes. Twelve-month results were recently published, demonstrating significant improvements in mean IPSS from baseline (-13.5; p < 0.0001), QoL (> 60%; p < 0.0001), BPHII (> 70%; p < 0.0001), and Qmax (range 90%-129% improvement; p < 0.0001). 46 Froma safety standpoint, there was a 0%observed rate of post-procedure device-related serious complications, meeting the safety primary endpoint. Furthermore, there were no reported cases of de novo ejaculatory or erectile dysfunction. When results were compared to and combined with the original L.I.F.T. study, similar effectiveness and improvement of LUTS was found for treatment of lateral andmedian lobes. Further studies may help to continue expanding the indication and utility of PUL for treating median lobes in BPH. 7 Benign prostatic hyperplasia: an update on minimally invasive therapy including Aquablation